PALFIQUE ESTELITE LV CLEAR— 510(k) K010267

Name: FDA 510(k) clearance K010267
Creator: U.S. Food and Drug Administration
Published: 2001-02-27

Substantially Equivalent

Tokuyama America, Inc.

FDA 510(k) clearance K010267 for PALFIQUE ESTELITE LV CLEAR, Substantially Equivalent on 2001-02-27. Applicant: Tokuyama America, Inc.. Device class: 2.

Clearance details

Applicant: Tokuyama America, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2001-01-29
Decision date: 2001-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.